Infanrix Precautions

Guillain-Barré Syndrome. There is a causal relationship between tetanus toxoid and Guillain-Barré syndrome. Guillain-Barré Syndrome is a condition in which the immune system attacks the nerves.

Latex. The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.

Fainting. Fainting has been reported following vaccination with Infanrix.

Adverse reactions with prior pertussis (whooping cough) vaccination. If any of the following events occur within the specified period after receiving a pertussis vaccine, the decision to get Infanrix vaccine should be based on careful consideration of potential benefits and possible risks.

Temperature of ≥40.5°C (105°F) within 48 hours, not attributable to another identifiable cause.

Collapse or shock-like state (hypotonic-hyporesponsive episode (HHE)) within 48 hours.

Persistent, inconsolable crying lasting ≥3 hours within 48 hours.

Seizures with or without fever within 3 days.

Previous history of seizures. For infants or children with a history of previous seizures, an appropriate fever reducer may be given at the time of vaccination and for the following 24 hours, to reduce the possibility of post-vaccination fever.

Premature infants may temporarily stop breathing. Short instances of no breathing following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer Infanrix to an infant born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

Allergic reactions. Tell your healthcare provider about any signs or symptoms of allergic reactions, which include the following:

chest pain

swelling of the face, eyes, lips, tongue, arms, or legs

difficulty breathing or swallowing

rash

Do not get Infanrix if you or your child:

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, or to any component of Infanrix

had encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause

Infanrix Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Infanrix, there are no specific foods that you must exclude from your diet when receiving this medication.

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had a severe allergic reaction (eg, anaphylaxis) after a previous dose of Infanrix vaccine or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine

had encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause

Infanrix and Pregnancy

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Infanrix falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Infanrix should only be given to a pregnant woman if clearly needed.

Infanrix and Lactation

It is not known if Infanrix crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using Infanrix.

Infanrix Dosage

Infanrix is given as a shot by your healthcare provider into the thigh or upper arm.

A 0.5-mL dose of Infanrix is given in infants and children 6 weeks to 7 years of age (prior to the seventh birthday) as a 5-dose series. The series consists of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. The first dose may be given as early as 6 weeks of age.

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